Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer

NCT05422183 | Unknown Phase 2

• 1 other identifier: ENLEN-OC-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, open-label, exploratory clinical study, the main purpose is to evaluate the combination of envafolimab, lenvatinib VP-16 in the treatment of platinum-resistant recurrent epithelial ovarian cancer，primary fallopian tube cancer and primary peritoneal carcinoma.

Conditions

Ovarian Cancer, Epithelial

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  6 months

Secondary Outcomes (4)

• OS

  12 months

• PFS

  12 months

• DCR

  9 months

• AEs AEs

  12 months

Study Arms (1)

envafolimab，lenvatinib，VP-16

EXPERIMENTAL

envafolimab：400mg，sc，d1，Q3W； lenvatinib：8 mg(BW\<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W； VP-16：50 mg/d, po,d1-14，Q3W

Drug: Envafolimab; Drug: Lenvatinib; Drug: VP-16

Interventions

Envafolimab DRUG

400mg，sc，d1，Q3W

Also known as: Immunotherapy

envafolimab，lenvatinib，VP-16

Lenvatinib DRUG

8 mg(BW\<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W

Also known as: Tyrosine kinase inhibitors

envafolimab，lenvatinib，VP-16

VP-16 DRUG

50 mg/d, po,d1-14，Q3W

Also known as: Chemotherapy

envafolimab，lenvatinib，VP-16

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years；
• ECOG 0-1
• Life expectancy of at least 3 months；
• Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer； Ovarian cancer patients with drug-resistant recurrence after platinum-based chemotherapy；
• At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
• Satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
• Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects；

You may not qualify if:

• Suffered from other malignant tumors within 5 years before the start of treatment in this study;
• Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
• Subjects with any severe and/or uncontrolled disease ；
• Poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10 mmol/L) ；
• Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture；
• Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ；
• Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ；
• Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ；
• Allergic to the active ingredients or excipients of the study drug ；
• Unsuitable for the study or other chemotherapy determined by investigator.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• Ding B, Yu T, Zheng S, Xu J, Ji F, Lin H, Zhao X, Qiu S, Shen Y. Combination therapy for platinum-resistant ovarian cancer: a novel at-home regimen with envafolimab, lenvatinib, and etoposide. Oncologist. 2025 Sep 1;30(9):oyaf210. doi: 10.1093/oncolo/oyaf210.

  PMID: 40658469 DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

envafolimab; Immunotherapy; lenvatinib; Tyrosine Kinase Inhibitors; Etoposide; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Yang Shen, MD

  Zhongda Hospital

  STUDY DIRECTOR

Central Study Contacts

Yang Shen, MD

CONTACT

025-83262742; shenyang0924@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)